MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-04-18 for MILTEX 19-385 * manufactured by Miltex Instrument Co. Inc..
[192425]
During irrigation of pt's ear, the top of the syringe dislodged with force and the tip punctured the pt's ear drum.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 274167 |
| MDR Report Key | 274167 |
| Date Received | 2000-04-18 |
| Date of Report | 2000-03-29 |
| Date of Event | 2000-01-07 |
| Date Facility Aware | 2000-01-07 |
| Report Date | 2000-03-29 |
| Date Reported to Mfgr | 2000-03-29 |
| Date Added to Maude | 2000-04-21 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MILTEX |
| Generic Name | SYRINGE, IRRIGATION |
| Product Code | KCP |
| Date Received | 2000-04-18 |
| Model Number | 19-385 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 265376 |
| Manufacturer | MILTEX INSTRUMENT CO. INC. |
| Manufacturer Address | 6 OHIO DR LAKE SUCCESS NY 110420006 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-04-18 |